The sleep apnea syndrome afflicts an estimated 1% to 3% of the general population and is due to episodic upper airway obstruction during sleep. Those afflicted with sleep apnea experience sleep fragmentation and intermittent, complete or nearly complete cessation of ventilation during sleep with potentially severe degrees of oxyhemoglobin unsaturation. These features may be translated clinically into debilitating daytime sleepiness, cardiac disrhythmias, pulmonary-artery hypertension, congestive heart failure and cognitive disfunction. Other sequelae of sleep apnea include right ventricular dysfunction with cor pulmonale, carbon dioxide retention during wakefulness as well as during sleep, and continuous reduced arterial oxygen tension. Hypersomnolent sleep apnea patients may be at risk for excessive mortality from these factors as well as by an elevated risk for accidents while driving and/or operating potentially dangerous equipment.
Although details of the pathogenesis of upper airway obstruction in sleep apnea patients have not been fully defined, it is generally accepted that the mechanism includes either anatomic or functional abnormalities of the upper airway which result in increased air flow resistance. Such abnormalities may include narrowing of the upper airway due to suction forces evolved during inspiration, the effect of gravity pulling the tongue back to appose the pharyngeal wall, and/or insufficient muscle tone in the upper airway dilator muscles. It has also been hypothesized that a mechanism responsible for the known association between obesity and sleep apnea is excessive soft tissue in the anterior and lateral neck which applies sufficient pressure on internal structures to narrow the airway.
The treatment of sleep apnea has included such surgical interventions as uvalopalatopharyngoplasty, gastric surgery for obesity, and maxillo-facial reconstruction. Another mode of surgical intervention used in the treatment of sleep apnea is tracheostomy. These treatments constitute major undertakings with considerable risk of post-operative morbidity if not mortality. Pharmacologic therapy has in general been disappointing, especially in patients with more than mild sleep apnea. In addition, side effects from the pharmacologic agents that have been used are frequent. Thus, medical practitioners continue to seek non-intrusive modes of treatment for sleep apnea with high success rates and high patient compliance including, for example in cases relating to obesity, weight loss through a regimen of exercise and regulated diet.
Recent work in the treatment of sleep apnea has included the use of continuous positive airway pressure (CPAP) to maintain the airway of the patient in a continuously open state during sleep. For example, U.S. Pat. No. 4,655,213 and Australian patent AU-B-83901/82 both disclose sleep apnea treatments based on continuous positive airway pressure applied within the airway of the patient.
Also of interest is U.S. Pat. No. 4,773,411 which discloses a method and apparatus for ventilatory treatment characterized as airway pressure release ventilation and which provides a substantially constant elevated airway pressure with periodic short term reductions of the elevated airway pressure to a pressure magnitude no less than ambient atmospheric pressure.
Publications pertaining to the application of CPAP in treatment of sleep apnea include the following:
1. Lindsay, DA, Issa FG, and Sullivan C. E. "Mechanisms of Sleep Desaturation in Chronic Airflow Limitation Studied with Nasal Continuous Positive Airway Pressure (CPAP), "Am Rev Respir Dis, 1982; 125: p. 112. PA0 2. Sanders MH, Moore SE, Eveslage J. "CPAP via nasal mask: A treatment for occlusive sleep apnea, " Chest, 1983; 83: pp. 144-145. PA0 3. Sullivan CE, Berthon-Jones M, Issa FG. "Remission of severe obesity-hypoventilation syndrome after short-term treatment during sleep with continuous positive airway pressure," Am Rev Respir Dis, 1983; 128: pp. 177-181. PA0 4. Sullivan CE, Issa FG, Berthon-Jones M, "Reversal of obstructive sleep apnea by continuous positive airway pressure applied through the nares," Lancet, 1981; 1: pp. 862-865. PA0 5. Sullivan CE, Berthon-Jones M. Issa FG. "Treatment of obstructive apnea with continuous positive airway pressure applied through the nose." Am Rev Respir Dis, 1982; 125: p. 107. Annual Meeting Abstracts. PA0 6. Rapoport DM, Sorkin B, Garay SM, Goldring RM. "Reversal of the `Pickwickian Syndrome` by long-term use of noctural nasal-airway pressure," N Engl J. Med, 1982; 307: pp. 931-933. PA0 7. Sanders MH, Holzer BC, Pennock BE. "The effect of nasal CPAP on various sleep apnea patterns," Chest, 1983; 84: p. 336. Presented at the Annual Meeting of the Americal College of Chest Physicians, Chicago IL, October 1983.
Although CPAP has been found to be very effective and well accepted, it suffers from some of the same limitations, although to a lesser degree, as do the surgery options; specifically a significant proportion of sleep apnea patients do not tolerate CPAP well. Thus, development of other viable non-invasive therapies has been a continuing objective in the art.